Primarily responsible for Quality Systems involving Process Validation and Technical Transfer.
Work proactively to support manufacturing and customer requirements, regarding the quality system issues and discrepancies and will be directly involved in the execution of qualifications and validations and writing of protocols and reports.
Drive project work and ensure GMP compliance. Manage and drive Change Management process to ensure proper open and closure of all change controls. Support Regulatory Affairs requests that require Quality Assurance documentation.
Subject matter expert for the change process for entire site. Including rewriting the process and form and training the site.
Risk Management- QA point for risk assessment evaluation for all projects.
Project Support – QA contact for meetings regarding Product Design/Realization and commercial product support and deviation resolution.
Data Metric Analysis – Compile monthly financial and customer data to present to Leadership Council regarding critical metrics (Cost of Quality, Cost of Poor Quality).
Leadership – Support Quality initiatives
The Quality Manager will lead quality team with implementation of company-wide operations procedures and process to support the overall quality assurance plan. This role supports Quality improvement throughout the operations process with a focus on manufacturing. Participate as cross-functional team member within assigned goal-oriented team responsibility.
HIgh visibility to Executive Management with clear career path to Director level.
Open to industry/product background … more important were the skills in validation, qualifications, data analytics….defining approach and discipline
Requirements:
BS Technical or Engineering
Experience developing Quality Systems, processes and documentation.
Capable of leading quality team.
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